Prevention of Recurrent C. Difficile Infection Study With AZD5148 Monoclonal Antibody
ConditionClostridioides Difficile Infection
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
The purpose of this study is to evaluate the efficacy and safety of AZD5148 for prevention of recurrence of Clostridioides difficile infection in Individuals 18 years of age and above.
Eligibility criteria
Qualifiers
Positive local C. difficile toxin test (eg, immune assay or CCNA) on an unformed stool sample collected during this episode, and
Receipt of standard of care antibacterial drug therapy for C. difficile infection (fidaxomicin, vancomycin or metronidazole) for this episode, with planned duration of at least 10 and at most 25 days at time of IMP administration.
Disqualifiers
None
Trial design
Treatments tested in this trial
- AZD5148
- Placebo
Treatment groups
230 Participants
are divided into 2 treatment groupsLocations
114Australia
Research Site2050, Camperdown Australia
Research Site3168, Clayton Australia
Research Site4029, Herston Australia
Research Site3000, Melbourne Australia
Sponsors and collaborators
AstraZeneca
Lead sponsor
Source ClinicalTrials.gov